Pelvic PainPhase 2NCT01143636
Transcranial Direct Stimulation in Chronic Pelvic Pain
A Phase 2 study testing Transcranial Direct Current Stimulation in people with Pelvic Pain and Healthy, run by Spaulding Rehabilitation Hospital at 1 site in United States.
Trial summary
The purpose of this study is to determine whether transcranial direct current stimulation (tDCS) is effective in reducing pain in subjects with chronic pelvic pain. Our hypothesis is that tDCS will decrease pain significantly when compared to sham stimulation. Read more about this study
- Who is it for?
- Ages 18 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Pelvic Pain, Healthy
- What is being tested?
- Transcranial Direct Current Stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 35 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2010to May 2013
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 64 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Providing informed consent to participate in the study
- 18 to 64 years old
- Having symptoms of pelvic pain for more than 6 months with an average of 3 on a 0-10 VAS scale (for pelvic pain subjects only)
- No history of or current genitourinary tuberculosis as self reported
- No history of urethral cancer as self reported
- No history or current bladder malignancy, high grade dysplasia or carcinoma in situ as self reported
Show all 28Show fewer
- No occurrence of ovarian, vaginal or cervical cancer in the previous 3 years as self reported
- No current vaginal infection as self reported
- No active herpes in previous 3 months as self reported
- No antimicrobials for urinary tract infections in previous 3 months as self reported
- Never treated with cyclophosphamide as self reported
- No radiation cystitis as self reported
- No neurogenic bladder dysfunction (due to a spinal cord injury, stroke, Parkinson's disease, multiple sclerosis, spina bifida or diabetic cystopathy) as self reported
- Absence of bladder, ureteral or urethral calculi for previous 3 months as self reported
- No urethritis for previous 3 months as self reported
- No urethral dilatation, cystometrogram, bladder cystoscopy with full anesthesia or bladder biopsy in previous 3 months as self reported
- Must not be pregnant
- Eligible to MRI according to MRI screening checklist
- No contraindications to tDCS:
- No history of alcohol or drug abuse within the past 6 months as self reported
- No use of carbamazepine as self reported
- Does not have severe depression (with a score of >30 in the Beck Depression Inventory)
- No history of neurological disorders as self reported
- No history of unexplained fainting spells as self reported,
- No history of head injury resulting in more than a momentary loss of consciousness as self reported
- Have had no neurosurgery as self reported
- No history of psychological disorders as self reported
- Must have the ability to feel pain as self reported
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Spaulding Rehabilitation Hospital
Boston, Massachusetts, 02114
About this study
Official title: Investigation and Treatment of Central Nervous System Dysfunction in Chronic Pelvic Pain.
The purpose of this study is to determine whether transcranial direct current stimulation (tDCS) is effective in reducing pain in subjects with chronic pelvic pain. Our hypothesis is that tDCS will decrease pain significantly when compared to sham stimulation.
Read the detailed description
The study encompasses two experiments: The first one involves patients with chronic pain, receiving 10 sessions of stimulation, active or sham (parallel design).
The second experiment involves involves healthy subjects, receiving active or sham tDCS over the primary motor cortex (crossover design).
- Conditions
- Pelvic Pain, Healthy
- Being tested
- Transcranial Direct Current Stimulation
- Keywords
- Transcranial direct current stimulation, Chronic Pelvic Pain
- Medical subject headings
- Pelvic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcranial Direct Current StimulationDevice
Also called tDCS, electrical stimulation
Chronic pain subjects will be randomized to receive either active or sham stimulation for the duration of the trial. The subject will receive 10 consecutive sessions at an intensity of 2mA with each session lasting 20 minutes. If the subject receives active stimulation the current will be applied for the full 20 minutes, while in the sham group current will only be applied for 30 seconds. In the healthy cohort, subjects will receive one session of active stimulation and one session of sham stimulation. The parameters will be the same as the pain subjects, at an intensity of 2mA for 20 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Active tDCS - pelvic pain patients | Sham comparator | ACTIVE tDCS: Subjects will receive a total of 10 consecutive sessions of active tDCS over a two-week period (administered Monday - Friday). During each session, the anode electrode will be placed over the primary motor cortex of the predominantly painful side. Receives: Device: Transcranial Direct Current Stimulation |
| Sham tDCS - pelvic pain patients | Experimental | SHAM tDCS: Subjects will receive a total of 10 consecutive sessions of sham tDCS over a two-week period (administered Mon-Fri). During each session, the anode will be placed over the primary motor cortex of the predominantly painful side. Receives: Device: Transcranial Direct Current Stimulation |
| Active tDCS - healthy | Experimental | The healthy controls will undergo one day of treatment with active tDCS. All participants will receive both active and sham stimulation in a randomized order. Receives: Device: Transcranial Direct Current Stimulation |
| Sham tDCS - healthy | Experimental | The healthy controls will undergo one day of treatment with sham tDCS. All participants will receive both active and sham stimulation in a randomized order. Receives: Device: Transcranial Direct Current Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Assessment
We use the Visual analogue scale (VAS) to measure pain. The VAS is ranged from 0 to 10, with 0 reffering to no pain and 10 reffering the the worst possible pain. We used the difference between post treatment minus baseline to compare the two treatments (active versus sham tDCS).
Measured: baseline and at 2 weeks
Pressure Pain Threshold
Pressure pain threshold (PPT) is defined as the minimum force applied which induces pain.
The change in pressure pain threshold (post minus pre intervention) is use for the analysis.
Measured: baseline and at 2 weeks
Secondary outcomes (9)
Quality of Life Scale (QOLS)
The questionnaire on quality of life was performed at the end of the treatment session and compared between the two groups (active and sham) in patients with pelvic pain (Exp. 1). The QOLS has 16 items (total scores ranging from 16 to 112) the highest scores corresponding the best QOL.
Measured: 2 weeks
Clinical Global Impression - CGI
This scale measures illness severity and was performed on patients with pelvic pain (Exp. 1). The scale was performed at end of the treatment and compared between the two groups (real and sham). The scale is divided in 3 sub-scales: Severity of illness (0-7), global improvement (0-7) and efficacy index (0-16), total scores ranging from 0 to 30. The highest scores corresponding to lowest clinical improvement.
Measured: 2 weeks
Visual Analogue Scale - Anxiety.This Scale Measures Patients' Level of Anxiety on a Scale (0-no Anxiety to 10-worst Anxiety Ever). It Was Performed at the End of the Treatment and Compared Between the 2 Groups (Real and Sham) in Patients With Pelvic Pain
The scale was performed at the end of the treatment and compared between the 2 groups (real and sham) in patients with pelvic pain (Exp. 1).
Measured: 2 weeks
Mini Mental Scale - MMS
This scale measures patients cognitive impairment. It was performed at the end of the treatment and compared between the 2 groups (real and sham) in patients with pelvic pain (Exp. 1). It is a 30 points scale (total scores ranging from 0 to 30), the highest score corresponds to the highest cognitive status.
Measured: 2 weeks
Beck Depression Inventory - BDI.
BDI is a questionnaire used for detecting depression. It was performed at the end of the treatment and compared between the 2 groups (real and sham) in patients with pelvic pain (Exp. 1). It is a 21-question multiple-choice self-report inventory (scores ranging from 0 to 63 - 0 corresponds to no symptom of depression).
Measured: 2 weeks
Patient Global Assessment - PGA
This scale measures patient's assessment of general health. It was performed at the end of the treatment and compared between the 2 groups (real and sham) in patients with pelvic pain (Exp 1). The patient has to answer the question "how is your health overall" on a scale going from 0 to 10 (0 being the worst, 10 being the best).
Measured: 2 weeks
Von Frey
This test is used to test subjects' sensitivity to a mechanical stimulus. It was performed before and and after the treatment and the difference (post minus pre) was compared between the 2 groups (real and sham) in patients with pelvic pain (Exp. 1). A set of filaments, typically from 0.008 grams force up to 300 grams force, is applied on the patients' skin. The mechanical threshold is defined as the moment when the patient detects the stimulus.
Measured: baseline and at 2 weeks
Pain Pressure Threshold Test - PPT
Pressure pain threshold (PPT) is defined as the minimum force applied which induces pain.This test was applied before and after the treatment and the difference (post minus pre) was compared between the 2 groups (real and sham) in patients with pelvic pain (Exp 1).
Measured: baseline and at 2 weeks
Diffuse Noxious Inhibitory Controls - DNIC.
DNIC occurs when response from a painful stimulus (pain pressure threshold - PPT) is inhibited by another noxious stimulus (cold water). The difference between baseline and post treatment was compared between the 2 groups (real and sham) in patients with pelvic pain (Exp. 1).
Measured: baseline and at 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2010 (estimated)
- Study startApr 2010
- Primary completionDec 2012
- Study completionMay 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Pelvic PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- For the experiment in patients with pelvic pain, the design is parallel. For the experiment in healthy subjects, the design is crossover.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Spaulding Rehabilitation Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Felipe Fregni, Spaulding Rehabilitation Hospital
- Investigators
- Felipe Fregni, MD, PhD, Principal investigator, Spaulding Rehabilitation Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01143636
- Sponsor's protocol ID
- 2009-P-002048
- Status last verified
- Apr 2020
- First submitted
- 20 Apr 2010
- Last updated
- 24 Apr 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation and Treatment of Central Nervous System Dysfunction in Chronic Pelvic Pain.
- ClinicalTrials.gov ID
- NCT01143636
- Acronym / sponsor ID
- 2009-P-002048
- Conditions
- Pelvic Pain, Healthy
- Keywords
- Transcranial direct current stimulation, Chronic Pelvic Pain
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Spaulding Rehabilitation HospitalUniversity, hospital or other
- Study start
- Apr 2010
- Primary completion
- Dec 2012 (actual)
- Study completion
- May 2013 (actual)
- First posted
- 14 Jun 2010 (estimated)
- Results
- Posted 15 Mar 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine whether transcranial direct current stimulation (tDCS) is effective in reducing pain in subjects with chronic pelvic pain. Our hypothesis is that tDCS will decrease pain significantly when compared to sham stimulation.
Detailed description
The study encompasses two experiments: The first one involves patients with chronic pain, receiving 10 sessions of stimulation, active or sham (parallel design).
The second experiment involves involves healthy subjects, receiving active or sham tDCS over the primary motor cortex (crossover design).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 4
- Model description
- For the experiment in patients with pelvic pain, the design is parallel. For the experiment in healthy subjects, the design is crossover.
| Arm | Type | Receives |
|---|---|---|
| Active tDCS - pelvic pain patients | Sham comparator | Device: Transcranial Direct Current StimulationACTIVE tDCS: Subjects will receive a total of 10 consecutive sessions of active tDCS over a two-week period (administered Monday - Friday). During each session, the anode electrode will be placed over the primary motor cortex of the predominantly painful side. |
| Sham tDCS - pelvic pain patients | Experimental | Device: Transcranial Direct Current StimulationSHAM tDCS: Subjects will receive a total of 10 consecutive sessions of sham tDCS over a two-week period (administered Mon-Fri). During each session, the anode will be placed over the primary motor cortex of the predominantly painful side. |
| Active tDCS - healthy | Experimental | Device: Transcranial Direct Current StimulationThe healthy controls will undergo one day of treatment with active tDCS. All participants will receive both active and sham stimulation in a randomized order. |
| Sham tDCS - healthy | Experimental | Device: Transcranial Direct Current StimulationThe healthy controls will undergo one day of treatment with sham tDCS. All participants will receive both active and sham stimulation in a randomized order. |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (28 listed)
- Providing informed consent to participate in the study
- 18 to 64 years old
- Having symptoms of pelvic pain for more than 6 months with an average of 3 on a 0-10 VAS scale (for pelvic pain subjects only)
- No history of or current genitourinary tuberculosis as self reported
- No history of urethral cancer as self reported
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transcranial Direct Current StimulationAlso: tDCS, electrical stimulationChronic pain subjects will be randomized to receive either active or sham stimulation for the duration of the trial. The subject will receive 10 consecutive sessions at an intensity of 2mA with each session lasting 20 minutes. If the subject receives active stimulation the current will be applied for the full 20 minutes, while in the sham group current will only be applied for 30 seconds. In the healthy cohort, subjects will receive one session of active stimulation and one session of sham stimulation. The parameters will be the same as the pain subjects, at an intensity of 2mA for 20 minutes. | Device | Active tDCS - healthy, Active tDCS - pelvic pain patients, Sham tDCS - healthy, Sham tDCS - pelvic pain patients |
Primary outcome
Pain Assessment
Time frame: baseline and at 2 weeks
We use the Visual analogue scale (VAS) to measure pain. The VAS is ranged from 0 to 10, with 0 reffering to no pain and 10 reffering the the worst possible pain. We used the difference between post treatment minus baseline to compare the two treatments (active versus sham tDCS).
Pressure Pain Threshold
Time frame: baseline and at 2 weeks
Pressure pain threshold (PPT) is defined as the minimum force applied which induces pain. The change in pressure pain threshold (post minus pre intervention) is use for the analysis.
9 secondary outcomes
Quality of Life Scale (QOLS)
Time frame: 2 weeks
Clinical Global Impression - CGI
Time frame: 2 weeks
Visual Analogue Scale - Anxiety.This Scale Measures Patients' Level of Anxiety on a Scale (0-no Anxiety to 10-worst Anxiety Ever). It Was Performed at the End of the Treatment and Compared Between the 2 Groups (Real and Sham) in Patients With Pelvic Pain
Time frame: 2 weeks
Mini Mental Scale - MMS
Time frame: 2 weeks
Beck Depression Inventory - BDI.
Time frame: 2 weeks
Patient Global Assessment - PGA
Time frame: 2 weeks
Von Frey
Time frame: baseline and at 2 weeks
Pain Pressure Threshold Test - PPT
Time frame: baseline and at 2 weeks
Diffuse Noxious Inhibitory Controls - DNIC.
Time frame: baseline and at 2 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Felipe Fregni, MD, PhD principal investigator
Spaulding Rehabilitation Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Transcranial Direct Current Stimulation in people with Pelvic Pain and Healthy, run by Spaulding Rehabilitation Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 28 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 15 Mar 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Assessment (time frame: baseline and at 2 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2020.